FilmArray GI Panel (2019-03-07)

Starting date:

March 7, 2019

Posting date:

April 5, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69474

Last updated: 2019-04-05

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  Reason
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  Affected products

Affected Products

FilmArray GI Panel

Reason

BioFire Diagnostics, LLC (BioFire) has identified elevated rates of false positive results for Campylobacter and Cryptosporidium while using the BioFire GI Panel. Only the BioFire GI Panel kits with expiration dates ranging from 10/23/2019 to 02/20/2020 are affected.  If using a BioFire GI Panel kit with an expiration date that is mentioned above, positive results for Campylobacter and Cryptosporidium should be confirmed by another method prior to reporting the test results.

Affected products